Food Insecurity Clinical Trial
Official title:
Pathways to Economic Mobility Pilot
NCT number | NCT05963763 |
Other study ID # | H-43633 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2024 |
Est. completion date | September 2025 |
Verified date | March 2024 |
Source | Boston Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Research on economic mobility barriers consistently demonstrates that lack of access to jobs that pay living wages and to asset building opportunities coupled with cliff effects across public assistance programs (families losing multiple benefits at the same time when their incomes increase) traps families in a cycle of poverty and food insecurity, and as a result, negatively impacts their financial well-being and physical and mental health. The investigators will explore the extent to which an Economic Mobility Pilot improves the financial well-being, physical and mental health, and reduces the social risks of study participants. Study participants will be eligible consented Boston Medical Center (BMC) employees. The intervention developed for this study consists of six months of coaching session offered by the Career Navigator. Participant will receive support on career and financial through services, such as career pathway navigation, employee benefit maximization, financial literacy, wealth building, resources, and referrals. A step wedge design will be implemented with participants randomized in two groups, Group 1, and Group 2 - intervention on different timeframe, analysis of the difference and similarities between groups pre- and post-survey. The qualitative component will include focus group of participants to provide information on the employee's perception of the intervention received, barriers to adherence and facilitators, and semi- structured interviews of the employer leadership to help assess the barriers and facilitators of the pilot. A primary aim of this research is to monitor changes in economic mobility and financial well-being. Additional aims are to investigate changes in household hardships and employee, employee depressive symptoms, and their child's health. The investigators will examine whether the participants in the intervention group compared to those before receiving the intervention, are more likely to: - Increase employee retention and self-reported financial well-being. - Improve self-reported food security. - Improve housing stability, energy security, childcare access, and/or health care access. - Improve employee self-reported physical health status, and/or reduce self-reported anxiety and depressive symptoms. - Improve employee-reported physical health status of the employee's child. - Cost of delivery of the intervention - Increased family income as result of this intervention
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Newly hired Boston Medical Center (hires since 2021) employees with children from the seven historically marginalized zip codes in Boston (mainly in the neighborhoods of Roxbury, Dorchester, and Mattapan) receiving hourly rate less than $35.00. Inclusion Criteria: - Recently hired Boston Medical Center employees, since June 2021 - Employees financially responsible for a child 18 years of age or younger - Employees who live in one of the following zip codes: 02119, 02121, 02122, 02124, 02125, 02126, 02130 - Employees who have Income threshold hourly wage of $35 Dollars Exclusion Criteria: - Employees who have been previously contacted by the Career Navigator - Employees not financially responsible for a child of 18 years old of age or younger - Employees not interested in receiving support from Career Navigator - Employees who do not accept consent - Employees who Do not reside in one of the seven zip codes |
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Medical Center | Boston University, Someone Elses Child, Wagner Foundation |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Financial well-being | Financial well-being will be assessed using the Consumer Financial Protection Bureau's abbreviated 5-item scale, covering aspects such as income, employment, savings, safety net, past financial experiences, and financial behaviors, skills, and attitudes. Ratings will be given on a scale from 0 to 4, indicating the level of description or frequency, with higher values representing stronger agreement or more frequent occurrences. The collected scores will be aggregated and categorized by age and administration type (self or external). The Item Response Theory (IRT) model will be employed to ensure the validity and significance of the items, while a higher score on the scale will reflect greater financial security. | 18 months | |
Primary | Food insecurity | Food security status over the past year will be assessed using the validated Abbreviated Child and Adult Food Security Scale (ACAFSS), which includes 6 household-specific and 2 child-specific questions. Household are classified into 3 categories: (1) household food secure (HFS) if one or none questions were endorsed as sometimes or often true, (2) household FI (HFI) if three or more, or the 4th question on household were endorsed, and (3) child FI if 2 or more child-specific questions were endorsed. | 18 months | |
Secondary | Housing instability | Participants will be categorized as experiencing housing insecurity (HI) if they report (1) being behind on rent/mortgage in the past year, (2) moving 2 or more times in the past year, and/or (3) homelessness within the child's lifetime. | 18 months | |
Secondary | Child Health Outcomes | Child health status will be characterized by caregiver rating of child health as excellent, good, fair, or poor, using a question from the National Health and Nutrition Examination Survey (NHANES). | 18 months | |
Secondary | Lifetime Child Hospitalizations | This outcome will be assessed by a question asked to the caregiver. Any hospitalizations will be defined as =1 hospitalizations in the child's lifetime, excluding the birth hospitalization. | 18 months | |
Secondary | Participant Health Outcomes | Child and subject general health status will be reported by the participating using validated questions from National Health and Nutrition Examination Survey (NHANES). | 18 months | |
Secondary | Parental depressive symptoms | Parental depressive symptoms will be collected using the Patient Health Questionnaire-2 (PHQ-2) which is a 2 question instrument with potential responses from 0 to 3 where 0=Not at all, 1=Several days, 2= More than half the days, and 4=Nearly every day. PHQ-2 scores range from 0-6. If the score is 3 or greater, major depressive disorder is likely. | 18 months | |
Secondary | Public program participation | Participants will be asked "yes or no" question on the following programs participation: Woman Infant and Child Program (WIC), Supplemental Nutrition Assistance Program (SNAP), and Transitional Aid to Families Needy Families (TANF). Medicaid, Earned Income Tax Credit (EITC), Subsidized housing or public housing, Energy Assistance, Water Assistance, Social Security (SSI) Disability Benefits (SSDI), Head Start or Early Start services, Free or reduced priced schools meals, Summer Meals, Childcare subsidy or voucher, Unemployment insurance, Electronic Benefit Transfer (EBT). | 18 months |
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